Philadelphia 7, Inc d/b/a Passional Boutique – FDA Warning Letter, Dec 1, 2025

The FDA issued a Warning Letter to Philadelphia 7, Inc., operating as Passional Boutique, on December 16, 2025. The agency reviewed the firm"s website and determined that it sells breast binders, which are considered medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act due to their intended use, such as helping reduce gender dysphoria. The primary violations identified involve the device manufacturer"s failure to annually register with the FDA and to list these devices, as mandated by section 510 of the Act. Consequently, these products are deemed misbranded under section 502(o) of the Act, and their introduction into interstate commerce is a prohibited act under section 301(a). Philadelphia 7, Inc. is required to take prompt action to address these violations. The firm must provide a written response to the FDA within fifteen business days of receiving the letter, detailing the specific corrective steps taken, including supporting documentation, and outlining plans to prevent similar violations in the future. Failure to adequately address these concerns may result in further regulatory actions, such as seizure or injunction. The comprehensive response should be sent via email.